Monday, October 27, 2025

Job Description

About the RoleI’m partnering with a global biopharmaceutical company to identify an experienced Regulatory Affairs professional to join their team as a Regulatory Process Excellence Consultant. This role will support key regulatory activities across multiple regions and drive continuous improvement within regulatory operations.Key ResponsibilitiesProvide regulatory support for marketed and pipeline products across the EU, ensuring documentation and submissions comply with regional requirements.Collaborate with cross-functional partners to align regulatory activities with business objectives and support successful product launches.Contribute to regulatory strategy and planning by coordinating input, reviewing submission materials, and facilitating timely interactions with health authorities.Drive process excellence by managing vendor performance, implementing best practices, and leading initiatives to enhance regulatory systems and compliance.Expertise & RequirementsProven experience in Regulatory Affairs within the pharmaceutical or biotech industry.Strong understanding of regulatory life cycle management in the EU.Experience supporting multi-regional submissions and post-approval activities (EU, UK, CH, CA, AU preferred).

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